[A randomized trial of conventional dose vs reduced dose in BHAC-DM therapy for acute myelogenous leukemia in elderly patients]

Rinsho Ketsueki. 2000 Feb;41(2):109-14.
[Article in Japanese]

Abstract

Twenty-nine patients aged 60-75 years with newly diagnosed acute myelogenous leukemia (AML) were randomized to receive BHAC-DM either at a reduced dose (S-1 group, n = 13; BHAC 150 mg/m2 1-7 day, DNR 30 mg/m2 1-3 day, 6MP 70 mg/m2 1-7 day) or the conventional dose (S-2 group, n = 16; BHAC 200 mg/m2 1-7 day, DNR 40 mg/m2 1-3 day, 6MP 70 mg/m2 1-7 day). On day 7, patients were given therapy for 2 more days if the ratio of blasts in their bone marrow was more than 15%. Granulocyte-colony stimulating factor was injected when the leukocyte count decreased below 1,000/microliter. The rates of complete remission were 46.2% in the S-1 group and 43.8% in the S-2 group. No significant differences in response distinguished the 2 groups. The mortality rate during myelosuppression was 1/13 in the S-1 group and 1/16 in the S-2 group. The rate of treatment-related death was 10.1% for all patients. Grade-4 adverse effects were not seen in any of the patients. We concluded that the conventional dose of BHAC-DM was as acceptable as the reduced dose in elderly patients with AML.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Cytarabine / administration & dosage
  • Cytarabine / adverse effects
  • Cytarabine / analogs & derivatives
  • Daunorubicin / administration & dosage
  • Daunorubicin / adverse effects
  • Drug Administration Schedule
  • Female
  • Humans
  • Leukemia, Myeloid, Acute / drug therapy*
  • Male
  • Mercaptopurine / administration & dosage
  • Mercaptopurine / adverse effects
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Prognosis
  • Prospective Studies
  • Remission Induction
  • Vincristine / administration & dosage
  • Vincristine / adverse effects

Substances

  • Cytarabine
  • Vincristine
  • Prednisolone
  • Mercaptopurine
  • Daunorubicin

Supplementary concepts

  • BHAC-DMPV protocol